Drugs / BBV154
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04751682 | Mar → Jun 2021 | Orthocoronavirinae infectious disease | Bharat Biotech International Limited | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05639998 | Sep 2021 → Mar 2022 | COVID-19 | Bharat Biotech International Limited | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 3 | NCT05522335 Comparator | Apr → Jul 2022 | COVID-19 | Bharat Biotech International Limited | Unknown | No outcome recorded |
| Phase 3 | NCT05567471 Comparator | Feb → May 2022 | COVID-19 | Bharat Biotech International Limited | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2022-11-28 | Bharat Biotech International Limited | Regulatory iNCOVACC®,World's first Intranasal Vaccine to receive both Primary series and Heterologous booster approval bharatbiotech.com ↗
iNCOVACC® recently received approval under Restricted Use in Emergency Situation for ages 18 and above for heterologous booster doses. |
| 2022-09-06 | Bharat Biotech International Limited | Regulatory Bharat Biotech's iNCOVACC® world's first Intra Nasal vaccine receives approval for emergency use in India bharatbiotech.com ↗
today announced that iNCOVACC (BBV154), has received approval under Restricted Use in Emergency Situation for ages 18 and above. |
| 2022-08-15 | Bharat Biotech International Limited | Results Bharat Biotech completes clinical development for phase III trials and booster doses for BBV154 intranasal covid vaccine bharatbiotech.com ↗
Hyderabad, Aug 15, 2022: Bharat Biotech International Limited (BBIL), a global leader in vaccine innovation and developer of vaccines for infectious diseases, today announced that BBV154 (intra nasal vaccine) has proven to be safe, well-tolerated, and immunogenic in subjects in controlled clinical trials. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-11-28 | Bharat Biotech International Limited | iNCOVACC®,World's first Intranasal Vaccine to receive both Primary series and Heterologous booster approval bharatbiotech.com ↗ |
| 2022-09-06 | Bharat Biotech International Limited | Bharat Biotech's iNCOVACC® world's first Intra Nasal vaccine receives approval for emergency use in India bharatbiotech.com ↗ |
| 2022-08-15 | Bharat Biotech International Limited | Bharat Biotech completes clinical development for phase III trials and booster doses for BBV154 intranasal covid vaccine bharatbiotech.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BBV154 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05567471 ↗ |
| Modality | Vaccine | “Replication deficient Adenoviral vector-based (expressing a stabilized spike protein) SARS-CoV-2 vaccine” NCT04751682 ↗ |
| Route | Intranasal | “via intranasal route” NCT04751682 ↗ |